This article was co-authored by Jennifer Boidy, RN. Jennifer Boidy is a Registered Nurse in Maryland. She received her Associate of Science in Nursing from Carroll Community College in 2012.

There are 19 references cited in this article, which can be found at the bottom of the page.

Before a drug or treatment can be approved for use in the United States, it must go through a series of clinical trials to determine its effectiveness and identify side effects. Clinical trials provide hope for patients suffering chronic medical conditions or incurable diseases, including various types of cancer. New drugs and treatment regimens are being developed all the time that have the potential to make people's lives longer and healthier. Even if you're in good health, there are many clinical trials that need healthy volunteers as well.[1]

Steps

Part 1

Finding an Appropriate Trial

1

Talk to your doctor. If you have a chronic illness or medical condition, your primary treatment provider is your best source for clinical trials that might benefit you. Let your doctor know that you are interested in exploring the possibilities.[2]

If you hear of a trial on your own, bring it up to your doctor and let them know you'd like to participate. They can advise you on whether they think you would benefit from the drug or treatment being studied.

2

Search lists on the internet. Government agencies, as well as nonprofit organizations and medical foundations, maintain lists of clinical trials currently seeking participants. Bookmark the lists you find so you can check them often.[3]

Lists are maintained by groups that sponsor clinical trials, including pharmaceutical companies and medical schools.

One of the largest sources is the database maintained by the National Institutes of Health (NIH), available at www.clinicaltrials.gov.

If you're looking for a clinical trial for cancer treatment, you may want to start with the National Cancer Institute (NCI), which sponsors most cancer-related clinical trials that receive government funding. Check their list at www.cancer.gov/clinicaltrials.

3

Identify and avoid scams. Especially if you have been recently diagnosed with a serious or life-threatening illness, you may be desperate for a "cure." But if something sounds too good to be true, it probably is.[4]

Protect yourself by doing background research into the doctors or facility conducting the clinical trial. If they've conducted trials for other drugs or treatments in the past, find out what you can about those trials and their outcome.

Look up doctors' licenses on the medical board website to confirm that they are licensed and in good standing, and have not been subject to any discipline.

Be wary of any clinical trials that guarantee a particular result, or claim that a drug doesn't have any negative side effects.

4

Sign up for a matching service. If you don't have time to look through long lists of clinical trials by yourself, you can get a matching service online to do the grunt work for you. Some of these services may require you to register, but most are free to use.[5]

You provide information to the service about your illness or condition, and the service will search through trial descriptions and eligibility criteria. Then it will return a list of clinical trials you are potentially eligible for.

5

Read the trial's protocol summary. While actual trial protocols may be more than 100 pages long, the summary provides important information about the purpose of the trial and the way it will be run. Some trials may have brochures or videos about the trial available as well.[6]

If you don't understand the protocol, reach out to someone on the research team. There should be contact information on the clinical trial listing. You also could ask your own doctor if they can offer any insight.

6

Evaluate the eligibility guidelines. Each trial has eligibility guidelines that list inclusion and exclusion criteria for people who can participate in the trial. All inclusion criteria must be met for you to take part in the study. However, if any of the exclusion criteria apply to you, you typically aren't eligible for the study.[7]

If you meet some, but not all, of the inclusion criteria for a clinical trial, talk to your doctor. They may be able to get an exception granted for you.

For example, suppose you're looking at the eligibility guidelines for a clinical trial for a cancer drug. To participate in the trial, you must be a female between the ages of 32 and 52 who has Stage 3 lung cancer. If you're a 30-year-old female, you're close to the criteria. Talk to your doctor and see if they can find out the reason for the age limitation and whether you can be granted an exception.

Part 2

Enrolling in a Clinical Trial

1

Ask your doctor for a referral. Getting a referral from your primary healthcare provider to participate in the clinical trial may be the quickest and easiest way for you be considered. For some trials, this is the only way you can get in.[8]

If you're a healthy participant, a doctor's referral typically isn't necessary. You can just contact the doctors running the clinical trial directly.

Depending on the purpose of the trial, a referral may have more value if it comes from a specialist than if it comes from your primary care physician. For example, if you want to participate in a clinical trial for a new epilepsy drug, you may want to get a referral from your neurologist.

2

Contact the clinical trial coordinator. The clinical trial coordinator will be named on the protocol summary for the trial. They will let you know what you need to do to apply to participate in the trial.[9]

If the trial has a website, you may be able to find information there. Contact and application information also may be available at the website of the organization or group sponsoring the trial.

3

Schedule a screening appointment. The trial coordinator must confirm that you're eligible to participate in the trial. Your screening appointment may include a physical exam and written or physical tests.[10]

During the screening appointment, a member of the research team will likely describe the trial for you and answer any questions you may have about the process.

If you have to undergo tests to determine your eligibility, you typically must sign a consent form before those tests are conducted.[11]

4

Ask for an exception if you're rejected from the trial. After screening, the trial coordinator may decide you aren't eligible to participate. If you had hopes that the trial would benefit your medical condition, you may be able to get a waiver or special exception.[12]

If you still want to participate in a trial despite being rejected, talk to your doctor. They can find out the specific reasons for your rejection and determine if the coordinator is willing to grant an exception.

When you participate under an exception, you are treated under the same protocol as the regular participants, but your information isn't included in the study. You may have to pay for costs of treatment.

5

Discuss the trial with family and friends. Before you sign up for a clinical trial, people close to you should probably understand the requirements for the protocol, as well as the possible benefits and risks of participation in the trial.[13]

Contact the trial coordinator or your own doctor if questions arise as a result of these conversations.

If you have a friend or family member who is acting as a caregiver with you, have them sit down with a research doctor in person. The doctor will answer their questions and explain what they need to do to assist you during the trial.

6

Sign the consent form. You must give your informed consent before you can participate in any clinical trial. The FDA has specific requirements that govern the kind of information you must be given about the clinical trial before you can agree to participate, including the risks and possible benefits, and alternative treatments that are available.[14]

The consent form will include specific written disclosures about the clinical trial. A member of the research team will go over the form with you to make sure you understand it.

The informed consent form also discusses your rights as a patient and details the care and treatment that will provided to you in exchange for your participation.

Part 3

Getting the Most out of Participation

1

Go over the protocol. Before the trial starts, a member of the research team will sit down with you and go over details of the treatment protocol. Your doctor may be present to help answer any questions as well.[15]

If there's anything you're confused about, speak up! It's important that you understand all the steps of the protocol and what you will have to do to participate in the clinical trial.

2

Complete your initial exam and testing. The research team typically needs blood work and imaging tests (such as X-rays or MRIs) done before the trial starts. This gives them a picture of your health condition before you start the experimental treatment.[16]

The research doctors also do a complete physical exam, and will get a complete medical history from you. If you're participating in the clinical trial to treat a chronic illness or medical condition, this history typically will be focused on that particular condition and what you've done to treat it so far.

3

Attend all appointments. When you're involved in a clinical trial, you may end up meeting with the research doctors more than you would normally meet with your regular doctors. Keep these appointments, even if you think you don't need to see a doctor.[17]

Normally when you get medical treatment, your appointments are based on your physical needs. With clinical trials, however, the research doctors balance your needs with the needs of the trial itself.

4

Communicate openly with trial researchers. Part of the purpose of a clinical trial often is to identify side effects of treatments. If you notice anything different, even if it doesn't bother you much, you still need to let the research doctors know.[18]

Don't try to play doctor. Even if you think a symptom is completely unrelated to the clinical trial, you still need to tell the research team about it. Let them identify the underlying cause of the symptom.

5

Follow up after the trial. Even after the trial is over, the researchers still may need to talk to you about your condition. You typically will be given the name and phone number of a member of the research team to contact if you have any concerns or notice anything that you think might be related to the trial.[19]

For example, suppose you participated in a clinical trial for an experimental cancer treatment, and your cancer went into remission. If it returns eight months after the trial is over, call the researchers and let them know. Likewise, if your cancer is still in remission after eight months the researchers may want to know that as well.

Community Q&A

Warnings

There may be unexpected side effects of the treatment that the doctor’s haven’t experienced in earlier phases of clinical testing.

The trial or your health insurance may not cover all of the costs you incur during the trial. Check with the directors of the trial and your health insurance company to understand what costs are covered before participating.

The treatment may not work for you, even if it does for other participants.